ANDA 207310, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 207310 (Sodium Chloride 0.9% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Sep 19, 2017, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection | Sodium Chloride | Rx |
| Aug 4, 2022 | Supplement 19Manufacturing | Approved | None posted |
| Nov 19, 2020 | Supplement 12Manufacturing | Approved | None posted |
| Jul 24, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 9, 2019 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 19, 2017 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
